Archive for September, 2009

John R Zaleski, PhD, CPHIMS

In this article I wish to provide some comments and highlight the functional requirements associated with high-acuity medical device communication in relation to the American Health Information Community (AHIC) priorities on common device connectivity (CDC) to electronic health records (EHRs).

The US Department of Health and Human Services Office of the National Coordinator for Health Information Technology has chartered the development of a series of documents to represent American Health Information Community (AHIC) priorities for national health information activities. The 2009 Common Device Connectivity (CDC) Extension/Gap document, as requested by AHIC, was commissioned to address information transfer from “high-acuity and inpatient diagnostic/therapeutic medical devices…into electronic health records.”

As stated in the scope of the CDC AHIC Extension/Gap, section 2.2, Common device connectivity is

“…the means by which high-acuity and inpatient clinical device information such as settings, measurements, and monitoring values are communicate to and from [the electronic health record] and other specialized clinical information systems.”

Examples cited include vital signs monitors, mechanical ventilators, anesthesia, and infusion pumps. Radiological devices are explicitly excluded from consideration. As such, single- and multi-parameter data from such devices are assumed the primary sources of data for communication to EHRs and clinical information systems (CISs).

It is noted, as stated within section 1.2 of the CDC AHIC Extension/Gap document, that as of the publication date of this CDC document, available at

http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_10731_848117_0_0_18/ComDevFinalExtGap.pdf, the national health agenda

“…has not formally addressed the interoperability considerations for connectivity between medical devices and EHRs.”

Progress has been made through the spring and summer of this year via the Tiger Team efforts initiated earlier this year, with focus on the Remote Monitoring Use Case. The 2008 Remote Monitoring (RMON) Use Case highlights communication from ambulatory settings to EHR and PHR. The functional requirements associated with CDC related to communication and exchange of information between medical devices and the electronic health record are highlighted in section 3.0 of the subject document. As is pointed out in the preamble to section 3.0, it is implicit in these functional needs that what are described are key capabilities and not detailed, explicit functional requirements, representative of those expected in a mission, software, and interface requirements specification. Rather, the focus is on the high-level functional needs.

My approach is to list each of the explicit functional needs (as quoted directly from the document—in italics) and then provide my feedback on the potential implications of each.

3.0 Functional Needs

A. The ability to configure and register a device to communicate with an EHR or other system.

i. When a device is set up within an organization to communicate measurement information, the device is configured and registered within the organization’s electronic health record to uniquely identify the device and enable connectivity between the device and system.

Zaleski:

This is usually a manual process today. The ability to associate a device with a patient is normally managed through the clinical software. One method is through the manual assignment via the clinical information system, such as through the critical care flow sheet. A pick list may be shown in which a clinician assigns the available devices to patients. Other approaches to associating medical devices with patients are being evaluated by various interoperability vendors, including the automated association via barcode or radio frequency identification token through a common device token, similar to a serial number.

B. The ability to associate patient identification and device information with an EHR.

i. Patient registration, location, and identification information available within the EHR is uniquely associated with the patient’s monitoring device using standardized mechanisms for admission, transfer, and discharge from beds, units, wards, and entities within the facility.

Zaleski:

Many vital signs monitoring systems provide methods for associating monitors in individual patient rooms with patients within a flow sheet, in the format of a bed board. Patients are assigned by nursing upon admission to the unit. The key identifying information can include a medical record number and visit identifier. Upon discharge, patients are disassociated using the bed board mechanism again. This process, while manual, addresses the point identified above.

ii. In the event patient identification information is associated with a device in error, the device can be disassociated with the current patient within the EHR and associated with the correct patient.

Zaleski:

Some clinical information systems (CISs) today provide the capability to disassociate the medical device from the patient through a flow sheet user interface. Those CISs that provide the equivalent of “bed boards” whereby patients are manually assigned to monitors (in rooms) via this user interface is one mechanism by which this can be accomplished.

iii. A patient may be placed on a monitoring device prior to the completion of patient registration or the availability of patient identification information within the EHR, especially in emergent or critical situations. The measurement information is available in the EHR upon initiation of the monitoring function or medical device initiation, and can be reconciled with patient registration or patient identification information within the EHR when available. Data collected prior to patient registration should be buffered and retained for a reasonable period of time sufficient to complete the registration process.

Zaleski:

Again, certain CIS flow sheets support this, with association or linkage to patient done after admission to the unit. The HL7 admission, discharge and transfer (ADT) messages arriving from an existing master registration system to the unit can then be used to link the patient-specific identifying information to the vitals data measured from the bedside equipment. Once linked, the observations and measurements can be sent back to electronic health records.

iv. Organizational policies and procedures may require medical device measurement values within a patient’s record to be validated by a licensed clinician prior to being stored within a patient’s record. This function may prevent the charting of erroneous values within a patient’s permanent medical record.

Zaleski:

The validation step is key to ensure that the data are indeed a true and accurate representation of the measurements from the patient. Furthermore, context added to the measurements (for example, clinical notes or text) that establish conditions at the bedside that may impact or influence the measured observations are also critical and necessary to communicate to the electronic health record.

C. The ability to associate patient identification and device information with an EHR.

i. Measurement and device information generated by the medical device is communicated to the EHR. Measurement information such as device settings, parameters, values, and units may be utilized by the EHR and/or clinical decision support (CDS) systems to support patient management.

ii. The devices should communicate state, error conditions, and user selections to support the analysis of adverse events.

Zaleski:

This causes me to think about the work I conducted when I was at PENN in the early 90s, and why I became involved in the field of medical devices and clinical decision making in healthcare. Having a complete and accurate record of the settings, parameter values, error conditions, etc. is certainly important for documentation purposes. But, moreover, it is essential to the “art” of making clinical decisions in an advisory role to the bedside clinician. What also speaks to me here is the necessity to begin thinking in terms of real-time management and monitoring of data—through the electronic health record! Again, it is certainly necessary to have a complete and accurate record of information from the documentation perspective. However, we should bear in mind that manual recording of this information has been done for decades. Presumably, benefits in terms of reduced errors, improved quality, and interventional guidance can be offered to the clinician by monitoring and recording this information in a timely manner. It would seem to follow that as much of this information is available in real- or near real-time, it would be beneficial to the patient to record information in as high a frequency as possible and practicable. Furthermore, status and error information that are logged could be made available to biomedical and IT departments for servicing and quality control purposes.

D. The ability to support point-of-care integration to uniquely identify a device and related components, communicate device setting and detailed device information, associated with each measurement value, to the EHR.

i. When a patient device is replaced by another device of the same type, measurement information may seamlessly populate the EHR. The devices may be from different manufacturers, but communicate the same information to the EHR. The EHR recognizes the measurement parameters and is able to represent the measurement values consistently within the EHR. Device information, settings, and metadata specific to each device is associated with each measurement value and is accessible within the EHR. This is accomplished via a standards-based first communication link interface between the point-of-care device and the EHR, device intermediary, or device gateway.

ii. A patient placed on multiple monitoring and patient care devices that need to be associated with the patient within the EHR. When multiple devices are capturing the same measurement or monitoring parameter, the information available within the EHR enables clinicians to distinguish between the measurements and determine the measurements that are captured from each device.

iii. Device data should be uniquely associated with the device, the patient, and the date and time the data was acquired, sent, and received.

Zaleski:

Standards-based communication from instrument or device gateways is typically accomplished using an HL7 result transaction. While the specific segment syntax can vary depending on the peculiarities of the device and the manufacturers’ objectives, this is more often than not the case. When device gateways do not exist, then the form of communication can be rather proprietary. Those in the device community are engaged in a continuing dialog on how to address this situation. Yet, from a clinical perspective, if two devices are interchanged (measuring the same parameter), then it may be in the interest to note the change in device as variations in device sensitivity, behavior, and manufacturing may result in some slight variation or difference in reported output. Yet, such variation should be well within the range of clinical significance so as not to raise a question as to the veracity of the result. Furthermore, one poor practice I have seen is representing two of the same values as two separate entries in flow sheets. For example, oxygen saturation from two different SpO2 cuffs. If these represent the same value (and not, for example, SpO2 and SaO2), then the values shown multiple times or presented in parallel with one another can cause confusion. While certain measurements can vary depending upon where measured (left arm versus right arm blood pressure measurement), and the differential is indeed necessary for clinical decision making, diagnosis and treatment, care must be taken so as not to present redundant measurements before the eyes of the clinician that may in fact be the same in every respect except for name. This simply will serve to confuse.

E. The ability to communicate measurement intervals and device setting information within the EHR.

i. When a patient is placed on a medical device, the clinician’s order details may specify measurement intervals for patient information to be communicated to the EHR.

ii. Depending upon patient acuity and monitoring needs, measurement intervals may need to be modified during the course of care. A clinician may modify the measurement parameters and intervals via the EHR or by modifying the device directly. Measurement interval information is communicated from the device to the EHR so the clinician may access this information.

iii. Inbound device settings and controls from the EHR may be subject to clinical oversight, validation and verification at the point of care prior to execution on the instrument itself.

iv. Measurement intervals are reconciled against the system time available from the EHR to ensure consistent and accurate identification of time intervals in absolute time.

v. The communication of multiple interval types should be supported (e.g. episodic, regular, quasi-continuous, sampled waveform, continuous waveform).

Zaleski:

An example that is used in clinical practice is the ordering of initial support on mechanical ventilation upon admission to an intensive care unit (ICU) of a post-operative coronary bypass graft patient. For instance, upon admission, initial ventilator settings of intermittent mandatory ventilation (IMV) at 12 breaths per minute, with a forced inspired oxygen of 100% and a positive end expiratory pressure (PEEP) of 5 cmH2O might be ordered. Then, as the patient is weaned down, the order is changed over time.

F. The ability to query the device or device intermediary [Zaleski adds: I interpret this as the device gateway] for additional information captured by the device that may not have been communicated to the EHR.

i. A clinician may request certain intervals for viewing device measurements or information within the EHR. If a patient event occurs that requires further investigation, the clinician may utilize the EHR to query for additional retrospective device information or measurement details that were not initially communicated to the EHR based upon the data intervals set for the patient.

Zaleski:

Clinical information systems that support automated collection at the bedside typically display automated vital signs information in discrete intervals. These intervals can vary. Typical ranges are one set of parameters every several minutes to once an hour, with typical values being in the quarter-hour range (i.e., once every 15 minutes, or q15). Flow sheets and their supporting medical device interoperability software need to allow for more or less frequent collection of information. The challenge remains that unless medical devices at the point of care provide for local storage of their data (possibly through their intermediaries), there may be no possibility to recall retrospective data on a patient.

G. The ability to communicate device and measurement information to the EHR when there is a lapse in EHR connectivity.

i. If a break in network connectivity occurs, or other factors prevent device communication to the EHR, device and measurement information is communicated to the EHR when connectivity is restored. Upon establishing or re-establishing this connectivity, there is no loss of measurement information in the EHR. In addition, details associated with measurement or device settings are communicated with the appropriate timestamp and patient parameters (e.g., identification, device settings) present at the time of information capture at the device.

ii. A notification may be sent to the EHR notifying of the event in which data transmission or communications are lost between the EHR and medical device. This notification consists of a standard health and status message that confirms device connectivity and general operation.

Zaleski:

A necessary requirement and cannot be overemphasized. Quality of Service undergirds this. Assured delivery of medical device data must occur if we are to use such data for intervention. As manufacturers of medical devices evolve more towards a plug and play paradigm, perhaps analogous to USB 2.0, this will assist in achieving this requirement. What we are talking about here is intelligent connectivity: devices “know” to whom they were attached; their data are not lost in the event of inadvertent loss of connectivity; the data can be picked up from where it was lost upon reconnection. Some monitoring systems provide what is typically called a “full disclosure database” which, in many instances, can store up to 72 hours of moment-by-moment data on any given patient until that patient is discharged. However, this is done at a much higher frequency than is normally stored within electronic health records.

H. The ability to communicate standardized alarm types and alarm violation types to the EHR in near real-time.

i. If a medical device generates an alarm, the alarm information and details are communicated to the EHR in time to support clinician life support efforts and critical care activities. Both text-based and audible alarm information should be communicated. For example, when a clinician or patient modifies device settings such as patient-controlled analgesics that are out of range and generates an alarm, the alarm and associated device details are communicated to the EHR.

Zaleski:

If we expect episodic, regular, quasi-continuous, sampled waveforms, continuous waveforms to somehow be supported, then near real-time implies real-time to me. This presents an interesting quandary: if we are to communicate interventional information to the EHR, is it not implied that this information will, somehow, be used for interventional guidance? To me, this further implies a medical device, possibly requiring pre-market notification and substantial equivalent to existing monitoring systems and full-disclosure databases (Class-II regulatory implication).

I. The ability to set and communicate limits and safeguards for device settings from the EHR to a device.

i. Evidence-based guidelines or clinician preferences for device parameters or alarms may be communicated from the EHR or other systems to the device. For example, this would enable an infusion pump to be interrupted or paused based upon EHR information. Interrupts and pauses are not intended to be or imply closed loop control.

Zaleski:

Presumably, we’re talking about communicating notifications to clinicians who would then intervene and stop or adjust the device, since we’re not talking about closed loop control.

J. The ability to wirelessly communicate point of care device information from the device to a device intermediary or EHR.

i. Wireless communication of high-acuity and inpatient medical device information may require specifications for wireless networking that supports the critical nature of this information and can co-exist with other medical devices and wireless applications.

Zaleski:

Clearly key: high quality of service, secure, available, reliable wireless infrastructure. This is the subject of an entirely new discussion, and one that I will be bringing up in the future. From iPhones™ to BlackBerrys™, clinicians of the future will be relying on mobile device technology and will expect them to support their clinical workflow in ways we have not yet even considered.

Recent link from MDT Perspectives:

“Based on my experience, there are three specific technology areas that will draw out the biggest breakthroughs in medical devices. Bear in mind that there is, naturally, clinical functionality that will bring about great breakthroughs in terms of treatment at the point of care. However, in terms of large-scale, systemic impacts on society, the low-hanging fruit can be found in the following three areas.

•Real-time location of medical devices and association with patients via a common, standards-based methodology (e.g., barcode and radio-frequency identification). Associating patients with devices is mandatory to ensure positive patient identification and safety in an operational clinical environment.

•Standards-based (i.e., non-proprietary) data and information sharing among devices with emphasis on storage and retrieval of device data with enterprise health information systems. Ensuring compliance of individual devices—especially BP cuffs, glucometers, and spirometers—using an HL7 based standard will be necessary to ensure common communication and minimize custom development.

•Plug-and-play medical device operation with universally available, low-cost home-health monitoring appliances that can facilitate chronic disease management for the aging population. The ability to bring data to the family practitioner quickly and easily will be necessary to facilitate quality care for the ever increasing aging baby boomer population.”

Tim Gee is a Connectologist and, I am privileged to add, a friend of mine. Tim hosts his blog at http://medicalconnectivity.com. Several months ago Tim kindly hosted two blog posts of mine on medical device connectivity. You can read them here:

http://medicalconnectivity.com/author/johnz/

The earlier of these posts, titled “Medical Device Open Source Frameworks,” described a view I hold on developing a plug and play capability for medical devices, analogous to USB 2.0. The later post, “How Medical Device Connectivity Can Improve Outcomes in the SICU,” laid out a scenario for how medical device data is crucial to clinical decision making, in which an example scenario is described relative to coronary bypass grafting patients in surgical intensive care units (SICUs).

On September 10th and 11th, the Inaugural Medical Device Connectivity Conference was held at Harvard Medical School. Tim was the conference chair and the brainchild behind the conference. I presented a paper on clinical decision making and acute care patients and also sat on a panel focusing on the future of medical device connectivity. It is clear that this is an evolving area of need and interest, and one for which great investment need be made in terms of healthcare infrastructure in order to achieve seamless, reliable, scalable and safe communication between medical devices and electronic health records and supporting clinical information systems at the point of care. I will be writing more on this subject in the coming weeks and months.

John R. Zaleski, PhD, CPHIMS

I remember from my own experiences with my father after his stroke what it was like shuttling him from specialist to specialist in an effort to get him the care he needed. Although medicine and medical information technology is the field in which I earn my living, there’s always something educational about firsthand experience. I am quite familiar with the field of healthcare information technology, its foibles, its benefits and its potential impact on healthcare delivery. I ran a critical care product line for a large healthcare IT vendor and am now managing bioinformatics research for another. However, the experience one gains in actually participating and operating in and around the healthcare system in the United States is one that many of us have, many of us curse, and many of us appreciate. I’d like to direct attention to several aspects of the healthcare system that we, as Americans, may consider to be mundane. However, perhaps after reading this those so inclined might have their interests piqued and pay attention somewhat more acutely to these rather mundane items and this in and of itself may cause you to re-think how improvements in the system could benefit you and your families.
We are all familiar with visiting a physician office for the first time. You know the routine: you are handed a clipboard containing half-a-dozen pages or so in which you must disclose every torrid aspect of your life. You must hand over your insurance card so a copy can be made and you must list every medication, every tablet, every vitamin you take in quantity, type, label so that THIS physician has a clear picture of who you are and what has ailed you. Some people are more organized: they make copies of this information and merely re-copy onto the forms so that they do not have to make up their stories out of whole cloth. Others are not so organized. Regardless, this information is normally maintained by your primary care physician (PCP) and is seldom shared unless you explicitly ask for records or, perhaps, your PCP is one of the more “progressive” types using an in-house electronic medical record system. Alas, currently only a relatively small number of U.S. physicians make use of health information technology. The estimate is that 17 percent of U.S. physicians and between 8 and 10 percent of U.S. hospitals employ health information systems in the form of electronic medical records for capturing and maintaining patient medical data (David Blumenthal, 2009).
However, consider having to repeat this process for each physician you visit. This takes me back to the story of my father. My father, who passed away last August, had a stroke in 2003 at the age of 85. I’ll save the experience of the basic medical challenges for another article, but I will relate that the treatment process involved half a dozen specialists and allied health professionals. All of these individuals required similar information regarding his health and history. Each one of them required the information in a format similar to the method described above with clipboard and pen.
Let’s consider for a moment an alternate method for the requisite “data transfer” experience described above. Suppose that my father’s history, medications, allergies, treatments, etc. were all contained on a single “device,” such as something having the form factor and function of a Universal Serial Bus (USB), or memory, stick. Then, if each physician and specialty practice had the capability of reading such information from this device into an electronic record that employed common interfacing and formatting so that the information could be populated in a way that would be visible and accessible to each physician, a number of benefits would have resulted. First of all, the mere physical act of copying the same information over and over would not have been required. Secondly, the likelihood of inaccurately entering information could have been avoided. Given the fact that I was the primary source for data entry, I can attest to the fact that I am error-prone! Thirdly, having a complete and accurate list of his medications, his treatment plans, clinical notes, and orders all available would have provided to each specialist a comprehensive understanding of his history. This would have enabled each of them to communicate more effectively to determine how best to treat him without having to ask redundant questions of both him and me during the visit—more time could have actually been spent in treatment!
The capability and benefits described above are not out of our reach. The technologies exist to enable the scenarios described above. The benefit to patients is obvious, as can be discerned from even this simple telling. Improving healthcare delivery can be achieved without bringing rocket science to the practice—we can begin simply by doing what we currently do more efficiently and by bringing some good sense to the practice. We as citizens think nothing about going to a store and using a credit card to pay for goods and services. Yet, we have nothing equivalent in standard practice that allows us to treat the most precious good: our bodies. In the coming weeks I hope to expand upon this theme and raise awareness on the benefits of information technology and its benefits to healthcare.

One of the chronic ailments that my father suffered from was the wet (or neovascular) form of macular degeneration. Neovascular macular degeneration affects about 10% of those patients who suffer from macular degeneration in general [1]. While there currently is no means of stopping or reversing the effects of macular degeneration, certain therapies (laser photocoagulation) can stem the bleeding associated with the wet form of the disease.

The effects on my father were heartbreaking in many ways. In my father’s working life he was a writer and editor for a number of industries, including the New York Medical Society, Ford Truck Times Magazine, and he was an advertising executive back in the 60s at J. Walter Thompson advertising as well as having his own advertising agency in the 1950s. In summary, my father’s sight was key to his livelihood. This was a man who used to read the New York Times cover to cover almost daily. In the last 5 years of his life, as a result of this ailment and the stroke he eventually suffered, he was left sightless and unable to enjoy the one thing that truly gave him pleasure.

I’m certain that many of us have equally poignant stories. During the 5 year period of both chronic and continuing medical care my father required I spent a great deal of time running him from specialist to surgeon to primary care physician to therapy and back again. I recall very vividly having to run him into Philadelphia from his home in the suburbs—about a 60-70 minute drive—for the purpose of having his eye surgeon review his progress. I remember how stressful the situation used to be: it was a fairly major production getting him out of the house and driving him down and back as he required assistance due to limited mobility. Oftentimes the visits were merely checkups of no more than 5-10 minutes duration. It was at these times that I used to ponder whether having a remote video and picture taking capability could have accomplished precisely the same thing: if his surgeon had the ability to review a photo remotely, my father could sit in the comfort of his home and have a retinal camera that I or another care giver could use to take a picture of his retina which could then be transmitted and reviewed by the surgeon remotely. Then, the visit could have been accomplished through a telecommunication session, in which the surgeon could speak with him directly over the telephone while reviewing the image. This would provide context for the imagery as well as provide for a much less stressful environment for my father.

Recently, Healthcare IT News reported “remote monitoring not only saves unnecessary trips to the emergency department, but prevents readmissions to the hospital” [2]. Unfortunately, the same article reports “healthcare payers are resistant to providing reimbursement for remote patient monitoring.” A chief reason for this seems to be the fact that the payer-provider reimbursement model is not adequately structured to take advantage of the benefit.

It would seem to me that the use of the technology would reimburse itself. Ignoring the time spent in traveling to and from the surgeon’s office, consider the fact that the visit itself could be shortened and accommodated on a schedule that could make most effective and efficient use of both parties: patient and provider. For example, a virtual office visit could be held at any time during the day (not just during “normal” office hours) and could even be managed from the provider’s home office. Of course, key to this would be the availability of a patient record in which information could be securely uploaded (e.g.: retinal imagery). A personal health record could have served this purpose. Furthermore, the relaxed setting of the patient’s home would have enabled a much more relaxed environment for the patient.

While the scenario I have described is not unique, it serves to illustrate a broader need and provides a compelling motive for telehealth and telecommunication. By linking healthcare information technology with existing means for communicating over telephone lines it is possible to achieve ends that will ultimately benefit chronically and elderly patients. In the next installment, I will address the benefits for other diseases, including stroke and glucose, and how the case for healthcare information technology has real benefits for the homebound or chronically ill patient.

[1] “Macular Degeneration,” http://www.stlukeseye.com/Conditions/MacularDegeneration.asp. St Lukes Eye Accessed May 3rd 2009.

[2] Bernie Monegain, “Remote patient monitoring improves outcomes for chronically ill, study shows.” Healthcare IT News. March 24^th, 2009.

By John R. Zaleski, PhD

Estimates by the U.S. Census Bureau expect the population of Americans aged 65 and older to increase by more than a factor of two between 2010 and 2050 [1]. At the same time estimates of healthcare expenditure increases between 2007 and 2017 show an increase to nearly 20% of GDP in this period [2]. These estimates were made prior to the recent financial crisis that began during the Fall of 2008. Further compounding this increasing demand and the concomitant increase in costs is the availability of allied healthcare professionals. Some studies [3] identify the likely decrease in the number of physicians entering any number of key specialty areas, including cardiology (20% decrease by 2020), geriatrics (35% of current demand met today), rheumatology (38 day average wait for a new appointment), and primary care (on the verge of collapse). Those of us who are baby boomers are on the leading edge of this demand and, in order to mitigate and minimize the cost impacts on our children, it is our challenge and responsibility to innovate and meet these challenges without passing along unnecessary burdens to our children and grandchildren.

For most of us, aging means more frequent and severe afflictions. Taking care of our health by improving diet, exercising, and maintaining an otherwise active lifestyle is essential to ensure a high quality life. Even with increased vigilance chronic ailments can affect us later in life, brought on both by our genetics and consequentially due to the lifestyles we’ve led in our youths. Ailments such as dementia, coronary artery disease, Alzheimer’s, myocardial infarction, congestive heart failure, macular degeneration, osteoporosis, hypertension, chronic obstructive pulmonary disease, diabetes, and others take their toll. Managing chronic diseases is costly from a logistical perspective in terms of time and money. However, even more to the point, effective and quality oversight of patients with chronic ailments requires regular review, screening, and monitoring of patients. This is further complicated by the need to serve patients who lack the means or are physically incapable of leaving their homes for extended periods. Telehealth and remote monitoring are a means by which a case manager—an individual assigned to oversee the care of chronically ill patients within a home-health setting—can review patient information on a regular basis (for example, daily) and support both the patient and the primary care provider. Furthermore, Intensive care units and emergency departments are becoming more crowded. Individuals with insurance are going to EDs because they cannot find satisfaction in terms of prompt scheduling with their gatekeepers (family practitioners). The quantity of individuals with chronic ailments is on the rise (stroke, CHF, diabetes, COPD, etc.) This is in part due to the fact that people are living longer. At the same time the Medicare and SS systems will not be able to sustain the growth in population over age 65. This means that working individuals will increasingly bear the financial burden for us “boomers.” As a result of increased longevity and the fiscal challenges, the retirement age will increase.

So, what do we do? Well, several things: first, technology in the form of remote data collection, reporting devices and software will become more prevalent: glucometers, BP cuffs, spirometers and associated software will be more readily available for direct communication with personalized electronic health records. If the purpose of a typical visit is to take BP and diabetic assessments, this can be handled most by collecting data at the point of care (home) and transmitting to the physician’s office for assessment. Such also applies to nursing and assisted living facilities. Next, the technical infrastructure required to transmit and store these data will be required. Paying for this infrastructure could come from a number of sources. One possibility: most everyone nowadays has access to cable television. Cable companies could offer devices that integrate with existing modems to collect and transmit data to the FP, together with complementary emails to next of kin (e.g. “Your mother’s BP as of 8:10 this morning was 145/89″). Other technologies that can be used to evaluate and monitor chronic ailments such as macular degeneration can further reduce costs by providing video cameras at point of care whereby opthalmologists can review retinal changes without requiring an elderly individual to be transported at expense and time to a hospital or office. In addition, support for remote consults via VoIP and video can be supported over the same network. This empowers the remote provider with the ability to interact with the patient All of these technologies are in use in remote pockets around the world today. But, they will become more prevalent. These technology implementations will reduce costs and provide for more personalized care in comfortable settings (homes). Of course, nothing takes the place of the tactile hands-on. But, for routine visits the above will be invaluable. In terms of the software technologies, personalized medicine will become the norm (eventually). Telehealth will be key. But, also, support for automated workflow in the acute care environment will need to be augmented. This means fully integrating all data into the enterprise HIS.

The U.S. Department of Health and Human Services through its Office of the National Coordinator for Health Information Technology, published operational scenarios focused on providing key information to assist in harmonizing standards on the implementation, certification, and policy implications for robust remote patient monitoring [4]. Included in this assessment are requirements on interacting with personalized health records and enterprise health information systems. The approaches to advancing remote monitoring include both seamless communication from medical devices at the point of care (i.e., in a patient’s home setting) and with a case manager and primary care provider both through electronic transfer, storage, and display of health information and remote video and audio interaction with patients in the same home health setting.

Technology is not the silver bullet, but those described above are key enablers for remote health monitoring. Of course, the use of technology carries with it the implication that sufficient underlying infrastructure exists. This is not always the case in remote areas of the country. Satellite, cable, and fiber optic technologies are fairly extensive within the continental United States, but pockets and regions exist in which this is not the case. Therefore, a combined effort to extend the communications infrastructure must continue together with a unified effort to standardize and train and “in-service” individual care providers on these technologies must occur. One of the best mechanisms for enabling this is through the local hospitals and their satellite clinics.

So, how long do we have? Well, the sooner the better. Successful telehealth and remote monitoring programs exist throughout the United States and worldwide today. We should ensure that our elected representatives direct healthcare expenditures towards several specific areas to promote growth and alignment to meet the objectives of remote monitoring. These include continuing alignment on electronic personalized health records, expansion of our underlying communications infrastructure, and promoting common standards of communication among these records so that, regardless of location, a patient can communicate his or her information to any physician and allied health professional within the country. In summary: common storage, homogeneous communication, standardized formats.
[1] Source: Population Division, U.S. Census Bureau, August 14th, 2008; Table 12: “Projections of the population by Age and Sex for the United States: 2010 to 2050 (NP2008-T12)”

[2] Cinda Becker, “Slow: Budget Danger Ahead,” Modern Healthcare, March 3rd 2008.

By John R. Zaleski, PhD

The average size of the avian influenza virus is on the order of 100 nanometers, or 0.1 microns. That a virus so small can wreak such havoc on the human body is a testament to the complex mechanisms associated with these infections. The ability to ward off such infections is also a testament to the awesome nature of the human immune system. By comparison, the width of a typical human hair is on the order of 100,000 nanometers (estimates put the range at 50,000 – 150,000, depending on the specific type of hair).

Now, consider the field of nanotechnology which focuses on the manufacture and fielding of mechanical and electronic devices of microscopic size, typically on the order of 100 nanometers or smaller. The National Cancer Institute (NCI) provides a fairly detailed overview of the use of nanotechnology in cancer treatment, and the NCI Alliance for Nanotechnology in Cancer is an initiative that provides a focal point for public and private investigation for the application of nanotechnology to the treatment of cancer. Researchers and companies have been investigating the manufacture of devices of this order of magnitude and smaller for application in the treatment of disease. A major focus for nanotechnology in healthcare is, not surprisingly, the treatment of cancer. Specific methods and modes of delivery vary. Examples include outfitting little “robots” with markers that will burrow into and attach themselves to cancerous cells for the purpose of enabling treatment and destruction of malignant cells. A major benefit of this approach versus traditional methods of radiation and chemotherapy is that the malignancies can be targeted directly without attacking or otherwise molesting healthy cells. This is a major advancement, since many of the current therapies that attack cells indiscriminately will kill both healthy as well as malignant cell material. When battling this terrible disease the last thing needed is to destroy those healthy cells upon which the individual depends for sustenance and survival. Thus, nanotechnology provides a mechanism for delivering targeted, customized, tailored therapy.

While we are on the cutting edge of the application of these technologies, the vision is real, and it is extremely promising. Treatment is only one aspect of nanotechnology use. Diagnosis is another area, in which nanoparticles can be used to assist in imaging of potential malignancies.

While almost a cliché, the aging of the baby-boomer population will drive a number of these new technologies, applications, and initiatives. It is almost a tautology that early diagnosis of disease  translates into a higher likelihood of survival. Technologies that support early diagnosis are, therefore, of great value and will enable better, more efficient, and  more accurate treatment of disease going forward. As a member of this generation (albeit, at the tail end), I am very encouraged and supportive of this research. I recall some 17 years ago when my mother passed away from breast cancer that the use of exotic technologies such as nanotechnology was barely an inkling. Indeed, the three oft-used mechanisms for treating cancer have remained surgery, irradiation, or poisoning (chemotherapy). It has only been within the past 10 years or so in which alternative therapies have been devised and discovered that are not simply variants of these three. Research into the targeted treatment of cancer by destroying the genetic material within malignant cells so that they cannot reproduce or cannot receive nourishment is an astonishing advancement and offers great future promise—a testament to human ingenuity, talent, innovation, and creativity. As in vitro and in vivo medicine evolve, such future-looking technologies will be essential in terms of early diagnoses and intervention.

By John R. Zaleski, PhD

There’s an old saying: if you want a new idea, read an old book. There’s another saying: those who do not learn from history are doomed to repeat it. Keep these two thoughts in mind as you proceed through this piece.

The healthcare “system” is really a system of systems. Enterprise health information systems (eHIS) are but one component of this system of systems. The integrated whole of the healthcare environment involves the technology, the people providing the care, the people managing the enterprise, the payers, and the workflow peculiarities of the environment in general.

Herein lies the old book. Those working in the aerospace industry are, perhaps, those most familiar with the system of systems integration concept. Systems integration has been a discipline employed by those working in the aerospace and defense fields. In these fields, large-scale systems need to be combined, coexist, and cooperate harmoniously within a larger context or framework. These frameworks, sometimes referred to as system-of-systems (SoS) architecture, are typically used to achieve component and interface commonality to promote reuse across separate and potentially disparate subsystems and components. The Department of Defense (DoD) published a framework [1] for establishing a coordinated approach for Command, Control, Communications, Computers, Intelligence, Surveillance, and Reconnaissance (C4ISR), whose principal objective was to ensure that architectures created and systems developed by various branches of the DoD would be synergistic and standardized across operational, technical, and organizational boundaries. Chen & Clothier [2] discussed the maintenance of sustainable and controlled SoS evolution. However, their application related to the concept of SoS with respect to military applications, as does the C4ISR, being chartered by the DoD.

Attempts to apply the C4ISR framework to commercial industry abound. Systems Engineering processes and Systems Integration as disciplines are being discussed and applied outside of the DoD domain in telecommunications and healthcare, to name two specific instances. However, even in these industries the main focus of SoS has been on the integration of a single product (that is, the product’s architectural components). This is somewhat different from large-scale, multi-system SoS architecture, in which separate stakeholders and developers, quite possibly outside of the integrating organization, must also participate in the overall solution.

So, what are the parallels to healthcare? Healthcare delivery involves wide-ranging, disparate, seemingly autonomous enterprises: hospitals around the country and around the world. Commonality exists in the form of (fairly) consistent clinical training: medical treatment protocols are the same regardless of where you go in the United States. Basic medicine and its teaching are consistent and uniform worldwide. Yet, the infrastructure to support patients and providers in the delivery of that care can vary from hospital to hospital; enterprise to enterprise; region to region; and country to country. For instance, take any emergency department (ED) in the U.S., and you will see basic medicine being practiced consistently (for the most part). But, depending on the sophistication, financial health, population, and training of the providers and supporting staff, the tools with which care is delivered and managed can be quite different. One ED may have a computerized tracking board for managing patients. Another may have a white board and no computers; yet another may record patients on a simple clipboard. The methods of management are different, but the approaches to care are the same. The benefits derived from more efficient management can be astonishing: lower mortality rates, higher throughput, and higher customer satisfaction.

Standardization across the healthcare enterprise is the subject of efforts by many standards and oversight organizations. One example includes the HL7 standard for healthcare data communication and interoperability standards related to medical device integration with electronic health information systems. But, where healthcare could benefit is by recognizing that this truly represents system of systems integration: each separate healthcare enterprise represents a separate system. The ability to communicate, interoperate, and exchange information among these separate enterprises is the subject and the goal of the system of systems: each autonomous enterprise can interact with its sister enterprise.

So, what are the benefits of achieving this result? One that resonates most closely to home is described in the following scenario. Consider falling ill in a foreign city—regardless of whether in country or globally—and being able to go to the local hospital and have all of your medical records displayed in a format consistent with that display in your home town. The benefit to you is any remote or foreign healthcare enterprise can have the complete detailed record of you. This mitigates errors, reduces the time required to provide treatment, and ensures that your entire history is accurately presented to any clinical user to provide the capability to manage your health better.

This is where history can teach us a lesson: those in the aerospace industry have understood this need for decades. However, the pace of progress has been much slower in healthcare than in the aerospace field. Yet, consider the benefits to patient, provider, insurer. Sometimes the cost of proliferating the not-invented-here attitude can have vast implications which complicate basic care. Healthcare would do well to think outside of its own “box” and draw upon the tools and stride the well-worn paths traversed by others in fields remote to medicine.

[1] C4ISR Architecture Framework, Version 2.0: Report of the C4ISR Architecture Working Group (AWG); 18 December 1997.

[2] Pin Chen, Jennie Clothier, “Advancing systems engineering for systems-of-systems challenges,” pp170-183, Systems Engineering Journal, Volume 6, Issue 3.